I get so tired of hearing people say that aspartame/NutraSweet/ Equal must be safe because the FDA approved it! They use it as justification to chug down Coke Zero and feed themselves and their children sugar-free jello, drinks, popsicles, yogurt and 6,000 other products on the market today. I want to try and dispel all the hype about aspartame and educate people as to how EXACTLY it was that aspartame came to be approved and generally recognized as safe (GRAS).
Aspartame was "discovered" in 1965 at the G.D. Searle Company when a chemist, Jim Schlatter, was working on treatment options for gastric ulcers. He accidentally spilled some of the heated chemical on his hand, licked his hand and noticed that it had a sweet taste. He and a friend decided to try the chemical - two amino acids bonded by methanol - in coffee and both agreed that it had a sweet taste. And aspartame was born. Upon this discovery, Searle simply changed the paperwork they were submitting to the FDA from a drug to a food additive, without changing the actual chemical at all. The FDA rejected it.
Fast forward to March 1973, Searle submits it's final research on aspartame along with it's first petition to the FDA that aspartame be approved for use in food. In 1974, aspartame was approved by the FDA for use in carbonated beverages and in dry products. However, in December 1975, the FDA task force concluded that some of Searle's studies were questionable and the FDA withdrew the 1973 approval. But that didn't stop the G.D. Searle company from continuing to push for re-approval of aspartame as a food additive, not a drug.
In October 1980, amidst great controversy and corporate pressure for the re-approval of aspartame, the FDA gathered a Public Board of Inquiry (PBOI) to evaluate aspartame's safety. The PBOI advised against the approval of aspartame finding that it caused an unacceptable level of brain tumors in the animals tested. "The Board has not been presented with proof of a reasonable certainty that aspartame (NutraSweet) is safe for use as a food additive under it's intended conditions of use."
Shockingly, the FDA again approved aspartame for consumer use in 1981. To many medical practitioners and consumer interest groups, the approval was a gross betrayal of public trust; especially as the approval seemed tainted by heavy financial interest. How could all of this really happen? No doubt there were apparently some questionable decisions behind the FDA approval of aspartame and it appears the approval was not for the benefit of you and me. Here's why, according to Jim Turner, Washington consumer attorney and author of The Chemical Feast: The Nadar Report on the Food and Drug Administration. Turner has actively opposed aspartame's approval since the 1970's.
"Searle, a drug company with little experience in food regulations, began studies on aspartame to comply with the FDA approval process, but they failed to do so," states Turner. The early tests of the chemical additive showed it produced microscopic holes and tumors in the brains of mice, epileptic seizures in monkeys and was converted by animals into dangerous substances, including formaldehyde.
In 1974, however, in spite of the information in its files, the FDA approved aspartame as a food additive. But the agency also made public, for the first time, the data supporting the food-additive decision. This data was then reviewed by renowned brain researcher Dr. John Olney from Washington University in St. Louis, as well as other research scientists.
Dr. Olney discovered two studies showing brain tumors in rats and petitioned the FDA for a public hearing. Consumer Action for Improved Foods and Drugs, represented by Mr. Turner, also petitioned for a public hearing based on "the approval process having been founded on 'sloppy' science" and on the reports showing aspartame caused epileptic seizures in monkeys and damage to the human eye.
Dr. Olney had already demonstrated in laboratory studies that aspartic acid (forty percent aspartame) caused microscopic holes to form in the brains of rats after each feeding. Aspartame also includes fifty percent phenylalanine, which is proven to harm children with PKU and methyl (wood) alcohol, which is a carcinogen and extremely neurotoxic in large amounts.
Faced with this array of possible health dangers, the FDA granted the hearing requests. In lieu of withdrawing its aspartame approval, the agency requested that Searle refrain from marketing the sweetener until after completion of the hearing. It then proposed that a Public Board of Inquiry (PBOI) review the matter.
In July of 1975, as the FDA prepared for the PBOI review, an FDA inspector conducted a routine inspection of Searle's Skokie, Illinois testing facility and found many "deviations" from proper procedure protocols. This report led the FDA commissioner, at the time, to create a Special Commissioner's Task Force to review Searle's laboratories.
In December of that year, the Task Force reported serious problems with Searle's research on a wide range of products, including aspartame. It found 11 other pivotal studies conducted in a manner so flawed that it raised more doubts concerning aspartame's safety and created the possibility of serious criminal liability for G.D. Searle. The FDA then delayed aspartame's approval. It also contracted, over serious internal objection from several FDA representatives, a group of university pathologists (at Searle's expense) to review most of the studies and a task force was eventually set up to review three selected studies. The U.S. Attorney for Chicago requested a grand jury review of a 1960's monkey seizure study.
Not surprisingly, the pathologists paid by Searle only reviewed one part of Searle's laboratory protocols: Searle's failure to properly report data. Not surprisingly, they did not re-open the study's design or conduct protocols. And lo and behold, the Searle-funded pathologists foundno serious problems. The FDA task force, on the other hand, found Searle's key tumor safety study unreliable, but their recommendations were ignored.
FDA Chief Counsel Richard Merrill submitted a 33-page letter to U.S. attorney Samuel Skinner recommending a grand jury investigation into G.D. Searle "for concealing material facts and making false statements in reports of animal studies to establish the safety of aspartame." Two specific studies of concern were cited. No action was taken, and Skinner allowed the statue of limitations to run out. Along with two of his aides, Skinner joined Searle's law firm shortly after that.
During the time period these committees met, the FDA organized the PBOI. G.D. Searle and the FDA Bureau of Foods each nominated three members for the board and the FDA commissioner selected one member from each list they submitted. In October 1980, based on its limited review, the board blocked aspartame marketing until the tumor studies could be explained. Unless the FDA commissioner overruled the board, the matter was closed.
The next month, November 1980, Ronald Reagan was elected U.S. President. Donald Rumsfeld (former congressman from Skokie, Illinois, former White House Chief of Staff and twice former Secretary of Defense) had been President of G.D. Searle since January 1977. He left Searle and joined the Reagan transition team. A full court press began against the FDA's board decision to suspend aspartame approval.
In January 1981, Rumsfeld told a corporate sales meeting attendee that he would call in his chips and get aspartame approved by the end of the year. On January 25th, the day President Reagan took office, the previous FDA commissioner's authority was suspended and the next month the appointed commissioner's job went to Dr. Arthur Hull Hayes.
According to Turner, transition records do not show why the administration chose Dr. Hayes, a professor and Defense Department contract researcher. In July of that year, Dr. Hayes, defying the FDA, approved aspartame for dry foods - his first major decision in office. In November 1983, the FDA approved aspartame for soft drinks - Hayes' last decision. Hayes was under fire for accepting corporate gifts and left the agency to work at Searle's public-relations firm as senior medical advisor. Shortly after the FDA soft-drink approval, Searle began test marketing and complaints began to arrive at the FDA's doorstep.
The complaints were more serious than the agency had ever received on any food additive. At the same time, independent research scientists began looking more closely at the dangers of this manufactured chemical sweetener. In 1985, the FDA asked the Centers for Disease Control (CDC) to review the first 650 complaints on aspartame (there were over 10,000 registered complaints as early as 1991). The CDC realized that the symptoms in approximately twenty-five percent of the complainants stopped and then restarted, either purposely or by accident, when aspartame use was stopped and then restarted. The FDA discounted their report.
Time progressed and aspartame use increased and according to data released in 1995 - human brain tumors, like those in the animal studies, had risen 10% and previously benign tumors grew forcefully. Searle and the FDA deputy commissioner defended that the data posed no problem. Two years later, this FDA deputy commissioner became vice president of clinical research for Searle.
From 1985 to 1995, approximately 400 aspartame research studies were performed both by Searle researchers and independent scientists. Most interestingly, those studies finding no problems with aspartame were one hundred percent funded by G.D. Searle. All studies funded by non-industry sources raised very serious questions and doubts concerning aspartame's safety in the public food supply.
"Given this record, it is little wonder that many health-conscious people believe avoiding NutraSweet improves their quality of life," states Turner, "If and when a scientific consensus concludes that aspartame puts some, if not all , of its consumers at risk, it will be much too late. The point is to eat safely now. Remember: the brain you save may be your own."
Janet Starr Hull
US Food and Drug Administration